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China NMPA UDI and Device Registration Basics
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation and regulatory submission requirements.
LexisNexis Reed Tech is proud to be recognized by the Dental Trade Alliance as a solution provider for Unique Device Identification (UDI) to U.S. FDA and other Global Health Authorities
HORSHAM, Pa., May 18, 2021 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a...
What to Know About NDC: The Basics of National Drug Codes
The NDC Directory is a comprehensive database containing information on prescription drugs, OTC medications, and insulin products in the U.S., identified by unique 10-digit National Drug Codes assigned by the FDA.
Why You Need a UDI Specialist
Did you know there are multiple health authorities around the globe with current or future requirements for medical...
How to Utilize an Authorized Representative in UDI Submissions to Health Regulators
For medical device manufacturers and distributors, UDI product data submission to Health Authorities/Regulators is a multi-step process with rules and goals, much like a ‘team sport’.
Unique Device Identification (UDI) Update for South Korea
Are UDI requirements in South Korea similar to other health regulators? The short answer is 'not exactly'. In this...